“Pharma should start treating investments in IT as
a prerequisite rather than a luxury”

Ram Yeleswarapu,
President and Chief Executive Officer,
TAKE Solutions

“The predominant ly generic Indian
pharmaceutical industry has been voraciously
adopting technology solutions, more than
ever before,” says Ram Yeleswarapu,
President and Chief Executive Officer,
TAKE Solutions. Excerpts from an interview
Yeleswarapu had with Mahesh Kallayil.

Please let us know of TAKE Solutions complete
service and solution portfolio and their application
in life science industry
TAKE Solutions is a business technology company
with deep subject matter expertise in Life Sciences.
We serve the global pharmaceutical, biotechnology,
and medical device companies. Our solutions and
services cover the clinical, regulatory, and safety
functional areas at these companies and we work
closely with the business and operational decision
makers in bringing experimental drugs and devices
to market and provide extensive support in the post
approval life cycle management stage.

TAKE Solutions provides strategic advisory and
consulting services, license our IPR and enable
technology solutions along with enterprise software
partners, and support outsourcing of core functional
services. Our consulting services are primarily
extended to heads of businesses who are facing either
non-compliance issues cited by the regulators, or are
looking to set up process and governance structures
and establish best practices to prepare their respective
organizations for new and emerging regulations.

Our technology and engineering team builds and
maintains IPR based technology solutions for the
industry and also collaborates with leading enterprise
software companies like Oracle, EMC, Axway, Sparta
Systems, Generis Corp, DSG, etc. In several instances,
our partnerships extend into collaborative codevelopment
of value-added solutions for the industry.
Our solutions enable our customers to perform
their operations with greater efficiencies, enhanced
compliance with existing and emerging regulations,
and enable growth of their respective businesses while
controlling costs.

Deep expertise in the subject matter of clinical research
and drug development along with knowledge of global
regulations and cutting edge technologies allows us
to be the partner of choice for our customers, when it
comes to outsourcing of core functional services. To
ensure compliance with global regulations we provide
following solutions:

Standards based clinical data management

Statistical programming, biostatistics

Medical writing

Regulatory publishing

Submission management along with tracking and

Drug safety services

Our infrastructure and global presence allows us to
interact with the customer teams with ease, giving
them the requisite support and comfort, so that they may pursue core discovery and research
activities rather than development. TAKE is
also actively engaged in pursuing enhanced
analytics in the realm of Life Sciences R&D
and healthcare using unstructured data
artefacts, contained in legacy repositories
maintained by customers as well as
meaningful public domain data that is
monitored and moderated by experts in
the field.

As a business technology solution
provider, what is your perspective
on Life science industry in India?
What are the main drivers of life
science industry?
The predominantly generic Indian
pharmaceutical industry has been
voraciously adopting technology solutions,
more than ever before. A spate of noncompliance
and quality issues along with
enhanced regulatory scrutiny are forcing
companies to adopt best practices,
enhance their processes and systems and
make the necessary investments. TAKE’s
PharmaReady software suite is used by
most Indian pharmaceutical companies
to prepare, package, and submit their
ANDAs to global regulatory authorities
across highly regulated, semi-regulated
and unregulated markets. We also provide
drug safety systems, Quality Management
Systems, and serialization or track & trace
solutions for the industry.

What do you see as the biggest
challenges facing Life Science Industry
in India? In what ways do you see
TAKE Solutions helping to overcome
these challenges?
Accountability, transparency, awareness
and adherence to quality are paramount
and these are some big challenges that
the industry is faced with. The industry in
India also needs to invest more in R&D
efforts and make a deliberate attempt to
enhance their portfolio beyond generics.
Making drugs domestically affordable
in an already slim margin business is
quite a challenge which becomes the
motivating factor for them to compete in
the international arena. However, rising
costs and increased competition in the
global markets, compounded by enhanced
fees imposed by the regulators are sure
signs of a market that will plateau. A well
balanced strategy should include a pursuit
for Biosimilars and NCEs (New Chemical
Entities) alongside a healthy portfolio of
generics. The regulatory framework in
India needs to be stabilized as well and
should be conducive for clinical research.
Given the extensive prevalence of chronic
diseases and the widely stratified patient
population, pursuit of clinical research
under a well-defined and managed
regulatory environment will surely yield
safe, effective, and affordable drugs.

TAKE Solutions has been serving the Life
Sciences industry for a few decades and
has tremendous expertise and insights,
having worked with global customers
and regulators. We are advocates of
cGxP frameworks which are essential for
the industry, and we provide assistance
with laying the foundational strategies to
address the issues of quality, compliance,
and risk management. We can then extend
help with deploying systems, solutions,
and processes built upon best practices,
which will fortify the foundations upon
which companies can grow and scale.

Please brief us on the need for improved
connectivity between IT and life
science industry
IT can play a pivotal role in ensuring
adherence to regulations and compliance
requirements, while allowing the companies
to focus on growth. A well thought through
IT strategy can tremendously improve
efficiencies and collaboration between
the various departments, improve
accountability and provide transparency
which are key ingredients for building
relationships with global trading partners.
The Life Sciences industry should start
treating investments in IT as a prerequisite
rather than a luxury in order to gain the
trust and confidence of the stakeholders
of the healthcare ecosystem. It is equally
important to increase the awareness of
the stringent requirements of the industry,
which will ensure a top down and a bottom
up approach to quality and compliance
resulting in the adoption of best practices
and enablement of good processes.

Do you think life science industry is
still dubitative about how to use and
make the most of the new IT scenario?
Why is that?
We notice a gradual change in attitudes
in the industry towards adoption of
technology to solve business problems.
While much of this is because of the
increased regulatory scrutiny coupled with
quality and compliance issues that got
highlighted and which led to stiff penalties,
the industry awareness is improving. Cross
border M&A, partnership arrangements
with global partners, and a strong desire
to quickly get products approved and
commercialized in larger healthcare
economies around the world are spurring
a wave of investments. Globally, regulators
are increasing their own collaboration
efforts with agencies in other countries
and initiatives like IDMP (Identification of
Medicinal Product) and Track & Trace for
establishing the electronic pedigree of a
drug or a device are testament to this. The
industry needs to realize that regulations
are here to stay and will only increase
in stringency and frequency. Sitting on
the fence with respect to investments in
good governance, solid processes, and supportive technology solutions will only
complicate matters and will eventually
cause a dent in the ‘Make in India’
brand slogan.

How is technology changing the
relationship between Pharma and
Patients? And between Pharma
and Doctors?
Increased technology adoption by
manufacturers, providers of care (hospitals
and physicians) and insurance payers
is enhancing the connectivity between
these entities. Knowledge about drug
products and devices, potential adverse
events caused by their consumption and
changes in labelling are just some of the
key pieces of information that are now
readily available, thanks to the herculean
efforts by regulators around the world. The
decision to move from paper to electronic
and then make the information available
in a consumable format for the greater
good of the partners in the healthcare
ecosystem has opened up a plethora of
transparency initiatives.

Information is now far more readily
available than ever before and patients can
more easily learn about the authenticity of
a drug product. Two-way communication
channels can be established between the
physicians and the patients to provide
consultation, tips about diet and exercise
regimen and how to stay healthy and fit.
EHRs (Electronic Health Records) now
capture details of patient visits in a digital
format, making it easy to exchange health
records between the network of care
providers, thereby ensuring continuity
of care at controlled costs (procedures
need not be repeated unnecessarily) and
also ensuring that medication errors are
eliminated. Some healthcare economies
are vigorously pursuing quality of care
metrics aka ‘pay for performance’, whereby
readmission rates are being monitored
along with hospital acquired conditions and
other provider related issues that could
potentially escalate healthcare costs and
the overall burden of paying for it.

Going forward how do you see
IT solut ions to t ransform the life
science industry?
IT solutions are crucial to enabling
business and operational efficiencies,
and are drivers of growth while ensuring
quality and compliance which are essential
to the life sciences industry. While Indian
manufacturers need to steadily move up the
maturity curve of adoption of technology
while moving away from paper and legacy
practices, there is a transformational
element that can catapult us as a major
contributor to solving healthcare issues
in a significant way in the global arena.
With the advent of genomics and enhanced
repositories of knowledge on drugs and
diseases as well as environmental and
behavioural factors, a lot more can be
accomplished via R&D efforts than ever
before. India has a vast scientific talent
pool, a rich background of being the
largest generics producer by volume, and
a diverse patient population suffering
from chronic conditions like diabetes
and cardiovascular disease that can be
treated by a vast network of physicians
and state-of-the-art hospitals and clinics.
We need to figure out our own indigenous
strategy where affordability of care is
essential, while ensuring drugs are safe
and effective. Advancements in technology
can today enable deep analysis of data to
seek insights and inferences from clinical
research data on one hand and close the
loop with feedback from actuals findings
on the ground in the healthcare segment.

How is TAKE Solutions set up to adapt
new, innovative technology to keep a
pace with the changing dynamics of the
Indian life science market?
TAKE Solutions is a global business
technology solutions provider and our ability
to do knowledge share amongst ourselves
while keeping track of best practices and
new and emerging technologies gives us
an advantage. Steadily working over the
last decade, we have established a very
loyal set of customers in the sub-continent,
and frequent interactions and the strength
of the relationships that have been built all
these years are enhancing our business.
The experience of working with global
manu fac turers and regul a tors gives
us the foresight required to advise our
customers in India and today we are well
entrenched with Indian pharmaceutical
companies as partners of choice. Besides
helping them with ANDA regulatory dossier
submissions and other paper-to-electronic
transformational needs, we are now
deploying quality management systems,
drug safety systems, serialization and
track & trace systems, mobility solutions
on shop floors to avoid product mix-ups,
etc. to name a few.

Please detail about your future
plans in terms of strategic alliances,
capacity expansion, products launches,
investment, etc.
As a company, we are constantly on the
lookout for strategic opportunities via
M&A to enhance our global footprint as
well as capabilities and expansion of
leadership bandwidth. Simultaneously,
we are forging alliances and partnerships
with partners who have the right solution
for the right problem, thereby providing
increased value to our customers.
Wherever possible, we are co-developing
to co-own IPR, we have won a patent and
are building solutions leveraging it, we
have registered additional patents, and
are working towards launching additional
products and solutions for the industry.
Recognizing that innovation is key to
enterprise viability and value creation, we
are actively investing in building IP assets
across Life Sciences and Healthcare. Our
investments are commensurate to our
strategy of becoming one of the leading
and largest providers of knowledge,
relevant technology, infrastructure, best
practices and good governance, and
subject matter experts for an industry
that holds the hope and promise for a
world bereft of disease and suffering
for mankind.